Scarlet WhisperPT: a comfortable in-ear cue device to reduce sleep on the back for positional sleep apnea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants with obstructive sleep apnea linked to sleeping on their back will try WhisperPT, an investigational in-ear device that delivers soft audio cues to encourage a shift from supine to non-supine sleep. The trial will measure changes in the apnea-hypopnea index, the amount of time spent sleeping on the back, and how comfortable and easy the device is to use. Eligible adults aged 18 to 75 with a significant positional component and adequate nightly sleep will use the device during an at-home period. Data on safety, usability, and sleep quality will be collected to determine if this approach can improve OSA symptoms related to position. Findings will inform whether WhisperPT could offer a tolerable alternative or complement to existing positional therapies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosing sleep study identified a significant positional component to their obstructive sleep apnea (OSA) diagnosis as measured by at least a 50% reduction in Apnea-Hypopnea Index (AHI) while sleeping non-supine compared to supine
* Diagnosing sleep study included at least 40% of the night recorded in supine and at least 20% of the night in non-supine position
* Have an overall AHI \> 10 (4% desaturation)
* Diagnosing sleep study included a minimum of 5 hours total sleep time (TST)
* Willing to abstain from use of any other treatments for sleep-disordered breathing beginning at least 3 days prior to at-home study testing and for the remaining duration of their study participation
* Between ages 18-75
* Must be able to refrain from alcohol use during nights of at-home study testing
* Speaks and reads English sufficiently to understand the study informed consent, study instructions, and study materials
* Signs study-specific informed consent form

Exclusion Criteria:

-Active medical conditions that would prevent study participation as determined by the principal investigator, including: Inability to easily move from between back and side in both directions Inability to sleep in lateral or supine position due to injury or a medical condition OR inability to sleep in a non-elevated/ tilted bed

* Requiring medications to sleep
* Prior diagnosis of a significant other sleep disorder such as restless leg syndrome/periodic limb movement disorder, primary central sleep apnea, pronounced insomnia, parasomnias, central disorder of hypersomnolence, etc
* An active ear infection OR an ear infection within the past month OR a history of \>3 ear infections per year
* Unusual outer ear, including enlarged or extra small anatomy, that prevents device use
* Significant hearing impairment or ear skin issues, including:

Participants with cochlear implants or those who will be affected by small magnets in the ear

* Suffering from tinnitus
* BMI \>35
* Current use of any illegal drugs.
* Currently pregnant or currently lactating
* Current enrollment in a clinical study of any other unapproved investigational drug or device.
* Inability or unwillingness to comply with the study requirements.
* Any other condition or laboratory value that could, in the professional opinion of the investigator, potentially affect response or participation in this clinical study, or would pose an unacceptable risk to the participant.

Where it's running

• Peninsula Sleep Center
  Burlingame, California, United States Recruiting

Study contacts

• Principal investigator: Mehran Farid, M.D.
• Study coordinator: Michael Swertfager
• Email: mswertfager@sleepdev.com
• Phone: 408-499-6884

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.